People Don’t Fail, Processes Do

When a situation goes wrong,  look at your process and ask why. by Terry Smith Lean Enterprise Institute Lean isn’t only a mindset. It give...

The FDA Just Called! Are You Ready for an Inspection?

If the FDA calls to schedule an  inspection, will you be prepared? by David R. Butcher Marketing Communications, MasterControl If the U.S. ...

How to Respond to FDA Inspection Observations, Including Those You Dispute

by Martin Browning, President, EduQuest, Inc.  FDA expert investigator and rule-maker for 22 years Although FDA is strapped with limited r...

New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

Medical manufacturers live in a world where  regulatory compliance must always be considered,  including changes associated with IEC 60601. ...

New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

Risk management monitoring of production and post-production performance is critical  to help ensure safe and effective devices  in the mark...

Do You Really Want to Be An Executive In An FDA-Regulated Company?

If you don't want a visit from the  Department of Justice, pay attention  to the new enforcement policies  the DOJ is following. by Jam...

6 Ways Quality Managers Can Build a Culture of Quality

Agreeing on a definition of quality is just one way to foster a culture of quality in your company. by Beth Pedersen, Marketing Communicat...

How to Ensure You are Following the ISO 9001 Certification Process

These tips help ensure you are  following the correct processes  for successful ISO certification. by Stuart Patch Content Writer Compass As...

8 New Year’s Resolutions for Quality Professionals

by David R. Butcher Marketing Communications, MasterControl ‘Tis the season to set New Year’s resolutions. With 2015 behind us and a whole ...